The original Flume I design enabled a critical proof of concept as well as some important confirmatory testing. It proved challenging, however, to produce sufficiently consistently to meet the requirements for human clinical trials.
We decided to bring forward the task of identifying a manufacturing partner with the capabilities to develop with us a Flume II ‘design for manufacture’ - capable of being produced at the intended scale as well as meet the regulatory requirements. Since August 2019 we have been working with Biomerics, a major specialist OEM manufacturer based in Salt Lake City, Utah. We are delighted with the development of Flume II and have now given the go ahead for the design. The next steps are around design qualification and validation, in advance of seeking regulatory approvals and commencing first in human clinical trials. On the latter, we are grateful that the grant funding has been extended for the trials planned at Bristol and Southampton.
